Business Wire

European Commission Approves Seagen’s TUKYSA ® (tucatinib) for the Treatment of Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer

Share

Seagen International (Nasdaq:SGEN) today announced that the European Commission (EC) has granted marketing authorization for TUKYSA® (tucatinib) in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least two prior anti-HER2 treatment regimens. TUKYSA is an oral, small molecule tyrosine kinase inhibitor (TKI) of HER2, a protein that contributes to cancer cell growth.1,2

“This approval is a significant advancement for patients in Europe, who will for the first time have an approved medicine demonstrating a survival benefit for HER2-positive metastatic breast cancer after disease progression following two standard anti-HER2 treatment regimens,” said Prof. Dr. Med Volkmar Mueller, Deputy Director at the University Medical Center Hamburg-Eppendorf, Hamburg, Germany and investigator for the pivotal trial. “In the HER2CLIMB pivotal trial, the tucatinib combination regimen improved overall and progression-free survival compared to trastuzumab and capecitabine alone, including in patients with active, untreated or progressing brain metastases, a population with significant unmet need.”

“The TUKYSA combination is a landmark therapy for patients with HER2-positive metastatic breast cancer with or without brain metastases, extending overall survival in these patients after two prior anti-HER2-treatment regimens,” said Clay Siegall, Ph.D., Chief Executive Officer at Seagen. “We are pleased TUKYSA is now approved in Europe, and we look forward to further collaborating with individual countries to ensure it is available to patients.”

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion for TUKYSA in December 2020. The approval of TUKYSA is valid in all countries of the European Union, as well as Norway, Liechtenstein, Iceland and Northern Ireland.

HER2CLIMB Efficacy and Safety

Patients who received TUKYSA in combination with trastuzumab and capecitabine in the pivotal trial had a 46 percent reduction in the risk of cancer progression or death (PFS), the primary endpoint, compared to patients who received trastuzumab and capecitabine alone (hazard ratio (HR)=0.54 [95% Confidence Interval (CI): 0.42, 0.71]; p<0.00001) and improved overall survival with a reduction in the risk of death by 34 percent (HR=0.66 [95% CI: 0.50, 0.87]; p=0.0048). The most common adverse reactions occurring in 20 percent or more of patients who received TUKYSA were diarrhea, nausea, vomiting, stomatitis, AST increase, ALT increase, and rash.1

The pivotal trial, HER2CLIMB, is a randomized (2:1), double-blind, placebo-controlled, active comparator, global trial that enrolled 612 patients with HER2-positive unresectable locally advanced or metastatic breast cancer who had previously received, either separately or in combination, trastuzumab, pertuzumab, and trastuzumab emtansine (T-DM1 SmPC).

About HER2-Positive Breast Cancer

Patients with HER2-positive breast cancer have tumors with high levels of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. In 2020, more than two million new cases of breast cancer were diagnosed worldwide, including 531,086 in Europe.3 Between 15 and 20 percent of breast cancer cases are HER2-positive.4 HER2-positive breast cancer tends to be more aggressive and more likely to recur than HER2-negative breast cancer.4,5,6 Up to 50 percent of metastatic HER2-positive breast cancer patients develop brain metastases over time.7,8,9

About TUKYSA (tucatinib)

TUKYSA is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein. In vitro (in lab studies), TUKYSA inhibited phosphorylation of HER2 and HER3, resulting in inhibition of downstream MAPK and AKT signaling and cell growth (proliferation), and showed anti-tumor activity in HER2-expressing tumor cells. In vivo (in living organisms), TUKYSA inhibited the growth of HER2-expressing tumors. The combination of TUKYSA and the anti-HER2 antibody trastuzumab showed increased anti-tumor activity in vitro and in vivo compared to either medicine alone.

About Seagen

Seagen is a global biotechnology company that discovers, develops, and commercializes transformative cancer medicines to make a meaningful difference in people’s lives. Seagen is headquartered in the Seattle, Washington area, and has locations in California, Canada, Switzerland, and the European Union. For more information on the company’s marketed products and robust pipeline, visit www.seagen.com and follow @SeagenGlobal on Twitter.

Forward-Looking Statements

Certain statements made in this press release are forward looking, such as those, among others, relating to the therapeutic potential of TUKYSA including its efficacy, safety and therapeutic uses, and the potential to make TUKYSA available to patients in Europe. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the possibilities that we may experience delays or setbacks in seeking pricing and reimbursement approvals or otherwise in commercializing TUKYSA in Europe; that adverse events or safety signals may occur; and that adverse regulatory actions may occur. More information about the risks and uncertainties faced by Seagen is contained under the caption “Risk Factors” included in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 and the company’s Current Report on Form 8-K dated December 30, 2020 filed with the U.S. Securities and Exchange Commission. Seagen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

1

Europeans Medicines Agency. TUKYSA Summary of Product Characteristics (SmPC).

2

Anita Kulukian, Patrice Lee, Janelle Taylor, et al. Preclinical Activity of HER2-Selective Tyrosine Kinase Inhibitor Tucatinib as a Single Agent or in Combination with Trastuzumab or Docetaxel in Solid Tumor ModelsMol Cancer Ther2020;19:976-987.

3

Breast. Globocan 2020. World Health Organization. 2020. https://gco.iarc.fr/today/data/factsheets/cancers/20-Breast-fact-sheet.pdf

4

Loibl S, Gianni L. HER2-positive breast cancer. Lancet. 2017; 389(10087): 2415-29.

5

Slamon D, Clark G, Wong S, et al. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu onco­gene. Science. 1987; 235(4785): 177-82.

6

Breast Cancer HER2 Status. American Cancer Society website. https://www.cancer.org/cancer/breast-cancer/understanding-a-breast-cancer-diagnosis/breast-cancer-her2-status.html. Accessed March 9, 2020.

7

Freedman RA, Gelman RS, Anders CK, et al. TBCRC 022: a phase II trial of neratinib and capecitabine for patients with human epidermal growth factor receptor 2-positive breast cancer and brain metastases. J Clin Oncol. 2019;37:1081-1089.

8

Olson EM, Najita JS, Sohl J, et al. Clinical outcomes and treatment practice patterns of patients with HER2-positive metastatic breast cancer in the post-trastuzumab era. Breast. 2013;22:525-531.

9

Bendell JC, Domchek SM, Burstein HJ, et al. Central nervous system metastases in women who receive trastuzumab-based therapy for metastatic breast carcinoma. Cancer. 2003;97:2972-2977.

Contact information

Peggy Pinkston
+1 (425) 527-4160
ppinkston@seagen.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Colicity Inc. Announces Closing of $345 Million Initial Public Offering26.2.2021 23:00:00 CETPress release

Colicity Inc. (the “Company”) announced the closing today of its initial public offering of 34,500,000 units, including the underwriters’ exercise of their full over-allotment option for 4,500,000 units, at a price of $10.00 per unit. The units are listed on the NASDAQ Stock Market (NASDAQ) and began trading under the ticker symbol “COLIU” on February 24, 2021. Each unit consists of one Class A share and one-fifth of one redeemable warrant, with each whole warrant exercisable to purchase one Class A share at a price of $11.50 per share. Only whole warrants will be exercisable. Once the securities comprising the units begin separate trading, the Class A shares and warrants are expected to be listed on the NASDAQ under the symbols “COLI” and “COLIW,” respectively. Colicity Inc. is a blank check company formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses. The Company int

C3 AI and Baker Hughes to Provide Enterprise AI Solutions to Accelerate PETRONAS Digital Transformation Program26.2.2021 15:00:00 CETPress release

C3 AI (NYSE: AI) and Baker Hughes today announced an artificial intelligence (AI) collaboration with PETRONAS, a global energy and solutions company from Malaysia, to apply BakerHughesC3.ai (BHC3) technology across PETRONAS’s strategic digital transformation programs. As the custodian of Malaysia's national oil and gas resources, PETRONAS runs an extensive digital transformation program across energy operations to extract value from data. The adoption of AI as part of its overall program for improved oil and gas productivity, asset integrity, and safety supports PETRONAS’s commitment to provide clean, efficient energy solutions by harnessing the power of technology. PETRONAS will work with energy technology, data science, and AI experts at Baker Hughes and C3 AI to collaborate on projects focused on improved reliability of energy assets in critical operations. Utilizing Microsoft Azure, PETRONAS will deploy the BHC3™ Reliability application to further improve maintenance programs for g

Avania in Position for Next Stage of Growth26.2.2021 14:00:00 CETPress release

Avania, a leading global full-service contract research organization (CRO) focused on medical technology (MedTech) development, today announced that it has successfully refinanced its existing banking facilities with Crescent Capital Group. “This new banking facility allows us to accelerate our next phase of organic and acquisitive growth over the next few years,” said Edo van Houten, CFO of Avania. “This transaction is also a reflection of the progress we have made in our brand strategy and position in the market, and it demonstrates the confidence of the financial community in our operational and strategic plan.” Avania has navigated confidently through the COVID-19 pandemic, posting a strong year of growth in 2020 despite the pandemic. The company will continue its growth trajectory as a global MedTech-focused CRO, supporting products from concept through post-market support. MedTech is all Avania does, navigating innovative medical technologies to market effectively and efficiently

Ipsen Receives Positive CHMP Opinion Recommending Cabometyx ® in Combination With Opdivo ® as First-line Treatment for Patients Living With Advanced Renal Cell Carcinoma26.2.2021 12:37:00 CETPress release

Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for Cabometyx® (cabozantinib) in combination with Bristol Myers Squibb’s Opdivo® (nivolumab) for the first-line treatment of advanced renal cell carcinoma (aRCC). The European Commission, which has the authority to approve medicines for the European Union (E.U.), will now review the CHMP recommendation and a final decision on the application in the E.U. is expected in the coming months. “Advanced renal cell carcinoma is a disease that significantly impacts the lives of people around the world. We’re proud to be able to share that the CHMP has confirmed a positive recommendation for Cabometyx® in combination with Opdivo®, bringing this impactful new treatment option one step closer for patients,” said Howard Mayer, Executive Vice President and Head of Research and Development, Ipsen. “At Ipsen, w

Hiro Capital Leads $15 Million of Games VC Investment Into Snowprint Studios, Double Loop Games and Happy Volcano Games26.2.2021 09:55:00 CETPress release

Three international video game studios are the latest investments for Hiro Capital, the entrepreneur-led Venture Capital fund focused on backing innovators in Video Games, the Metaverse, Esports and Digital Fitness. The three mobile and cross-platform studios – Snowprint in Stockholm/Berlin, Double Loop Games in San Francisco and Happy Volcano in Belgium – will use Hiro’s investment to expand their development pipelines and accelerate global growth. They join UK and US Games studios Flavourworks, Polyarc and Lightfox in the Hiro Capital portfolio, alongside pioneers in the gamification of Games Streaming and Digital Fitness LIV.tv, Edgegap,FitXR and Nurvv. Ian Livingstone, co-founding partner at Hiro Capital, said, "We are excited to begin 2021 by announcing Hiro's investment in three amazing games studios, Snowprint, Double Loop and Happy Volcano. Each studio has demonstrated innovation and expertise in developing fun to play games which resonate with today’s audiences. I’m especially

Inspur Information Releases 2020 Global Computing Index Report26.2.2021 09:07:00 CETPress release

Inspur Information, a leading IT infrastructure solutions provider, has sponsored an International Data Corporation (IDC) white paper on the 2020 Global Computing Index (henceforth referred to as The Report). As the world’s first index report on computing, The Report unveils the relationship between computing power and economic development and serves as a reference for the outlook of the global digital economy. Global digital transformation has entered a phase marked by exponential growth in innovation, with the size of the digital economy projected to continue on an upward trend. As a key factor that underlies digital technology development, computing is now defining the productivity of the digital economy era. According to The Report, economic growth directly correlates with the development of computing—one point of growth in the computing index translates to a 3.3‰ rise in the size of the digital economy and a 1.8‰ growth in GDP. Specifically, AI computing market share is projected

Incyte Announces the Validation by the European Medicines Agency of its Marketing Authorization Application for Retifanlimab as a Treatment for Patients with Squamous Cell Anal Carcinoma (SCAC)26.2.2021 09:00:00 CETPress release

Incyte (Nasdaq:INCY) today announced the validation of the Company’s Marketing Authorization Application (MAA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell anal carcinoma (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The European Medicines Agency’s (EMA) validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process. “While the incidence of SCAC is increasing in Europe, treatment options for advanced disease are limited in their effectiveness, and there are no approved options once patients have progressed on standard therapy,” said Lance Leopold, M.D., Group Vice President, Immuno-Oncology Clinical Development, Incyte. “The EMA validation of the MAA for retifanlimab – which follows the recent U.S. Food & Drug Administration acceptance of our Biologics License Application for Priority Review – brings us